Active Ingredient
Minoxidil 5%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Viofairy 5% Minoxidil Hair Growth Oil (NDC 83804-106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5%
Hair Regrowth Treatment
to regrow hair on the top of the scalp
For external use only.
Flammable: Keep away from fire or flame
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• you do not know the reason for your hair loss
• you are under 18 years of age. Do not use on babies and children
• your scalp is red, inflamed, infected, irritated or painful
• you use other medicines on the scalp
• do not apply on other parts of the body
• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
• chest pain, rapid heartbeat, faintness, or dizziness occurs
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)
When Pregnant or breast-feeding
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
• using more or more often will not improve results
• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. It contains important information.
• hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men
• in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men proided more hair regrowth than minoxidil topical solution 2%
• store at 20-25° C (68-77° F). Keep tightly closed.
Biotin
Water
Ginseng Extroct
polygonum multiflorum Thunb
Angelica Sinensis
Cacumen Platycladi Orientalis
Carthamus Tinctorius L Extract
Ligusticum Chuanxiong Hort Extract
Cortex Dictamni
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